Biogen’s investigational tau-targeting therapy BIIB080 receives FDA fast track designation for the treatment of Alzheimer’s disease

Biogen

2 April 2025 - Biogen today announced that the US FDA has granted fast track designation to BIIB080, an investigational antisense oligonucleotide therapy targeting tau, for the treatment of Alzheimer’s disease.

BIIB080 is the first tau-targeting ASO to enter clinical development for Alzheimer’s disease and is currently being evaluated in the global Phase 2 CELIA study in individuals with early-stage disease.

Read Biogen press release

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track